Memorandum

Tidepool Loop submitted to the FDA for 510(k) clearance – January 8, 2021

iAGC (see more below on this designation) submission filed on December 22; Tidepool is looking for clearance later this year and to launch with Dexcom G6 and Omnipod compatibility

Tidepool announced yesterday that Tidepool Loop has been submitted to the FDA for 510(k) clearance as an interoperable automated glycemic controller (iAGC or “iController”). Per the press announcement, the FDA notified Tidepool of the submission’s acceptance on December 22, 2020. Tidepool expects a decision from the FDA “later this year” and aims to initially launch Loop with Dexcom G6 and Insulet Omnipod compatibility. That wide range in the timeline can likely be attributed to the unique nature of the submission and delays at the FDA, as the Agency continues to address mainly COVID-19-related devices, as we understand it. A number of other diabetes submissions are expected to take longer than usual – Senseonics published an update last month anticipating an “at least 60-day” delay for its 180-day Eversense and we believe that all device companies with US regulatory submissions are experiencing delays. Regardless, Tidepool’s submission is quite an accomplishment, just a little over two years after its original announcement (October 2018). For more on the iAGC designation and previous “iController” designation, see here and here. 

Tidepool Loop’s submission for its algorithm includes data from a human factors validation study (n>50) completed in November and 12-month results from an observational DIY Loop study (n=558), for which six-month data was published in DT&T in November. The original goal was just 150-300 participants and to have had over 550 participate is truly notable. Presumably, the submission also includes plans for training and customer and HCP support – we believe this will help spread the word on closed loop quite significantly.  

At present, Medtronic and Tandem, whose 670G and Control-IQ products are currently the only commercially available closed loop systems. Tidepool is not a pump or CGM manufacturer, but an algorithm and app. We expect Tidepool Loop will certainly provide a lot to those who prefer Omnipod to pumps that use traditional sets, just as Rileylink does so currently. As we understand it, Tidepool aims to have its ACE pump partners like Insulet in this case handle training for the pump itself, while Tidepool handles training for the algorithm and user interface of the app (Tidepool Loop).

Continuing its approach toward complete transparency that has been so educational for the field, Tidepool will publish all documents submitted to the FDA on its website after the FDA’s review is complete.

  • In the announcement, Tidepool pointed out that Tidepool Loop could become the first app for iOS cleared for the automatic dosing of insulin. In fact, Tidepool Loop could become the first app in the US to offer pump control, altogether. Tandem submitted smartphone pump control to the FDA for in ~November 2020 and anticipates clearance in 1Q20, though that timeline may not reflect potential delays at the FDA. Insulet’s own Omnipod 5 hybrid closed loop system is expected to launch in 1H21 with Android smartphone control; as we’ve speculated, all device timelines may change with global regulatory agencies focused on COVID-19.

  • As mentioned above, Insulet’s Omnipod 5 system is expected to be cleared and launch this year. Depending on the exact timing, we may see two Insulet-compatible AID systems reach the market at or near the same time, which both use the Omnipod patch pump and Dexcom G6 CGM, but that make use of different algorithms. Presumably the Rileylink approach would also still be available.

  • What’s next for Tidepool Loop? It’s been a whirlwind few months at Tidepool, culminating in this recent FDA submission. Tidepool completed its human factors validation study of Tidepool Loop in November and the fast publication of its six-month study of DIY Loop in DT&T in November. During the same stretch, the company also downsized, noting 40% of the team would be laid off due to the financial impact of COVID-19 in November. Presumably, Tidepool is now at work on regulatory discussions, putting together launch plans for Tidepool Loop once cleared, etc. As an iAGC, Tidepool will also be working to bring compatibility to other pumps and CGMs. A partnership with Medtronic was announced back in June 2019, though its status is somewhat unclear (see Medtronic’s 3Q20 remarks). Tidepool has also suggested new partnerships on the horizon in the past, though we haven’t gotten any further details on who the potential partners might be (Abbott or Tandem perhaps?). Finally, Tidepool also confirmed plans to eventually support Android smartphones back in October. Although HCPs and PWD who aren’t as familiar with the various approaches may have a lot to learn, along the way on which offering is which, Tidepool Loop is a notable addition.

Close Concerns’ Questions

  • How long will the FDA review for Tidepool Loop take? How much will the review be delayed by COVID-19?

    • Tidepool: We're already in contact with the FDA, answering their early rounds of questions, but we can't speak to the ways in which the COVID environment has changed or will change the way review periods are handled at FDA. We understand that there is uncertainty and that the agency will have certain limited time and resource constraints given the pandemic. On our end, we are aiming to be responsive and flexible. To that end, it wouldn't be at all prudent to speculate on when we might hear final word from them.

  • How quickly can Tidepool launch Loop once cleared?

    • Tidepool: Regarding our commercialization and launch strategy, we're continuing to work in coordination with our partners on the details and will share more when prudent to do so.

  • What will be the demand for Tidepool Loop?

  • How will Insulet, Dexcom, and iPhone users choose between Tidepool Loop and Insulet’s Omnipod 5 and the current Rileylink approach that many users us? Will the timing of the two systems’ availabilities make a difference?

  • On which factors will people with diabetes choose between Tidepool and DIY Loop? How closely will Tidepool’s and DIY Loop’s code bases be in the future? How often does Tidepool expect to provide updates/improvements to its version of Loop?

  • Are there plans to monetize Tidepool Loop in the future? How might that, or the lack thereof, affect the rest of the industry?

  • Who will be Tidepool’s next device partner(s)? What’s the status of the Medtronic partnership?

  • When will Tidepool/Jaeb give 12-month data from the Loop observational study and when will the results be published?

 

--by Katie Mahoney, Albert Cai, and Kelly Close